Fluoroscopy-Guided Lumbar Facet Block for Chronic Low Back Pain
Evaluation of Functionality and Pain After Fluoroscopy-Guided Lumbar Facet Block: A Prospective and Longitudinal Study
This prospective, longitudinal observational study evaluates functional recovery, pain intensity, and lumbar mobility after a fluoroscopy-guided lumbar facet joint block in patients with chronic lumbar facet syndrome. Forty patients receiving standard-of-care injections (ropivacaine 0.2% and methylprednisolone) will be observed. Outcomes are measured at baseline and 30 days post-intervention. The primary outcome is the change in Oswestry Disability Index (ODI). Secondary outcomes include changes in the Numeric Rating Scale (NRS) and the modified Schober test.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Chronic low back pain due to facet joint arthropathy is a common cause of disability.
Fluoroscopy-guided facet joint blocks are widely used in standard practice, but evidence quantifying objective functional and biomechanical recovery beyond pain reduction is limited.
This single-center, prospective, observational, longitudinal study aims to objectively quantify functional recovery. Forty patients aged 18-75 years with clinically and radiologically confirmed lumbar facet syndrome will be observed. The intervention (unilateral fluoroscopy-guided injection of ropivacaine 0.2% [0.5-1 mL] and methylprednisolone into the affected facet joint) is performed strictly as part of routine clinical care, independent of study inclusion.
Assessments occur at baseline (T0) and 30 days post-injection (T1). The primary outcome is the change in Oswestry Disability Index (ODI) score. Secondary outcomes are changes in Numeric Rating Scale (NRS) pain scores and the modified Schober test (cm). Adverse events and procedural safety are recorded. The study aims to provide preliminary effect estimates to inform future controlled trials.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Paola Estefania Vallejo Mora, MD
- Phone Number: +52 56 3125 6766
- Email: paovallejo100177@gmail.com
Study Contact Backup
- Name: Sergio Tenopala Villegas, MD
- Phone Number: +52 55 5412 0375
- Email: drstenopala@yahoo.com.mx
Study Locations
-
-
Mexico City
-
Mexico City, Mexico City, Mexico, 03229
- Centro Médico Nacional 20 de Noviembre, ISSSTE
-
Contact:
- Paola Estefania Vallejo Mora, MD
- Phone Number: +52 56 3125 6766
- Email: paovallejo100177@gmail.com
-
Contact:
- Sergio Tenopala Villegas, MD
- Phone Number: +52 55 5412 0375
- Email: drstenopala@yahoo.com.mx
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Adults aged 18-75 years with chronic low back pain (>3 months) due to lumbar facet syndrome confirmed by clinical examination and imaging, presenting to the Algology outpatient clinic.
Description
Inclusion Criteria:
- Age 18-75 years
- Clinical and radiological diagnosis of lumbar facet syndrome
- Low back pain duration >3 months
- Baseline NRS pain score ≥4/10
- Signed informed consent for the procedure and study participation
- Cognitive capacity to independently complete the Oswestry Disability Index
Exclusion Criteria:
- Radicular pain or confirmed disc herniation with neural compression
- Coagulopathy or use of anticoagulants not discontinued appropriately
- Active systemic or local infection
- Known allergy to local anaesthetics or corticosteroids
- Pregnancy or lactation
- Previous lumbar spine surgery at the same level
- Inability to comply with follow-up schedule
Study Plan
How is the study designed?
Design Details
- Observational Models: COHORT
- Time Perspectives: PROSPECTIVE
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Facet Block
Single group receiving standard-of-care fluoroscopy-guided lumbar facet joint injection of ropivacaine 0.2% (0.5-1 mL) and methylprednisolone into the affected facet joint(s). |
Under fluoroscopic guidance, a 20G Quincke needle is placed into the target lumbar facet joint or onto the adjacent medial branch. An arthrogram is performed with 0.3 to 0.5 mL of non-ionic contrast to confirm correct dispersion and exclude vascular/intrathecal uptake. Subsequently, 0.5 to 1 mL of a mixture containing ropivacaine 0.2% and methylprednisolone is injected per level. Performed on an outpatient basis under standard monitoring. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Oswestry Disability Index (ODI)
Time Frame: Baseline (pre-injection) and 30 days post-injection
|
The Oswestry Disability Index (ODI) is a 10-item questionnaire that measures functional disability in daily activities (0% = no disability, 100% = severe disability). The primary outcome is the change in ODI score from baseline to 30 days. A reduction of ≥10 points is considered clinically significant. |
Baseline (pre-injection) and 30 days post-injection
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Numeric Rating Scale (NRS) pain score
Time Frame: Baseline, immediately post-procedure, and 30 days post-injection
|
Pain intensity measured using an 11-point Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain). A clinically significant reduction is defined as at least a 50% decrease from the baseline score. |
Baseline, immediately post-procedure, and 30 days post-injection
|
|
Change in modified Schober test (lumbar flexion mobility)
Time Frame: Baseline and 30 days post-injection
|
The modified Schober test measures lumbar flexion range (cm) to evaluate biomechanical mobility. An increase of at least 5 cm indicates a functional range. |
Baseline and 30 days post-injection
|
|
Incidence of adverse events
Time Frame: Immediately after procedure up to 30 days post-injection
|
Record of any adverse events including pain at injection site, transient exacerbation of pain, allergic reaction, inadvertent dural puncture, spinal haematoma, or nerve root injury. |
Immediately after procedure up to 30 days post-injection
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sergio Tenopala Villegas, MD, Centro Médico Nacional 20 de Noviembre, ISSSTE
- Sub-Investigator: Paola Estefania Vallejo Mora, MD, Centro Médico Nacional 20 de Noviembre, ISSSTE
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RAI.CMN.373.2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
De-identified individual participant data underlying the results reported in this study, along with the full analysis code, will be made available following article publication via the corresponding author's public GitHub repository.
IPD Sharing Time Frame
Beginning at the time of article publication, with no end date.
IPD Sharing Access Criteria
Data and code will be publicly available with no access restrictions via GitHub.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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